Device recall
Z-0205-06: Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
FDA device recall · Class II · Namsa
Key facts
| Recall number (Z-number) | Z-0205-06 |
|---|---|
| Recall event | 31560 |
| Product | Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. |
| Product code | FRC |
| Recalling firm | Namsa |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2012 |
| 510(k) numbers | K994381 |
| FEI number | 1521876 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database